CSV Validation Specialist - Cell Therapy (AI-Accelerated)

Katalyst CRO

Lawrenceville (NJ)

On-site

USD 130,000 - 190,000

Full time

8 days ago

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Job summary

Katalyst CRO in New Jersey seeks a seasoned CSV professional to lead and support Computer System Validation activities for enterprise GxP systems, with a focus on cell therapy projects. This role works with validation leads to ensure deliverables and testing meet the Client CSV SOP.

Strong communication across Business, IT and Quality, plus expertise with validation tools and document management systems, is essential.

Qualifications

CSV experience in pharmaceutical/regulated environments.
Experience with data integrity/ALCOA+ principles.
Ability to interpret requirements across Business, IT and Quality.
Experience with regulatory practices (FDA/ICH).
Strong technical writing skills with attention to data integrity.
Proficient in document management and lifecycle tools.

Responsibilities

Support creation, review, and approval of CSV deliverables for in-house solutions.
Maintain communication with stakeholders on CSV needs and project status.
Create documents to established standards.
Respond to reviews by Business, IT, and Quality stakeholders.
Follow SOPs and industry best practices.
Utilize AI as an accelerator for document creation/review.
Collaborate with validation leads and cross-functional teams.